Major EU Market Country definition

Major EU Market Country means any of [***].
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Major EU Market Country means any of France, Germany, Italy, Spain or the United Kingdom.
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Major EU Market Country means [***].
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Examples of Major EU Market Country in a sentence

  • After [*] has been commercially launched in a Major EU Market Country, SpePharm shall use Commercially Reasonable Efforts to Commercialize [*] in each such Major EU Market Country.


More Definitions of Major EU Market Country

Major EU Market Country means any of [***]. 1.1.52. “Major Market Country” means any [***]. 1.1.53. “Manufacture” or “Manufacturing” means to make, produce, manufacture, process, fill, finish, package, label, perform quality assurance testing, release, ship or store, and for the purposes of further Manufacturing, distribute, import or export, a compound or product or any component thereof. When used as a noun, “Manufacture” or “Manufacturing” means any and all activities involved in Manufacturing a compound, protein, device or product or any component thereof. 1.1.54. “Methods” means any instructions, methods, processes, workflows and other techniques or protocols necessary or useful for use of the Instrument. 1.1.55. “Milestone Payments” shall mean the Technical Milestone Payments, the Development Milestone Payments and the Sales Milestone Payments. 1.1.56. “Milestones” means the Technical Milestones, the Development Milestones and the Sales Milestones. 1.1.57. “Net Sales” means: (a) with respect to a Product, the gross receipts from sales by Pfizer and its Affiliates and Sublicensees of such Product to Third Parties in the Territory, less in each case (i) bad debts and (ii) sales returns and allowances actually paid, granted or accrued, including trade, quantity and cash discounts and any other adjustments, including those granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, health care insurance carriers, chain pharmacies, mass merchandisers, staff model HMO’s,
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Major EU Market Country means any of the following countries: [ * ].
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Major EU Market Country means any of France, Germany, Italy, Spain or the United Kingdom, [***] Certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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Related to Major EU Market Country

  • Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.

  • Major EU Country Major EU Country means France, Germany, Italy, Spain or the United Kingdom.

  • Major Market means any one of the following countries: United States, Japan, the United Kingdom, France, Germany, Italy or Spain.

  • Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.

  • Major European Countries means France, Germany, Italy, Spain and the United Kingdom.

  • Major Markets means [***].

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Host Country means, with respect to an Insured Person, the country or territory the Insured Person is visiting or in which the Insured Person is living, which is not the Insured Person’s Home Country.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Major Country means the United States, Japan, France, Germany, Italy, Spain, and the United Kingdom.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Relevant Country means, as determined by the Calculation Agent, each of:

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Relevant market area means as follows:

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Free Trade Agreement country end product means an article that—

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.